AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients

This study has been completed.
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer Identifier:
First received: January 29, 2013
Last updated: February 9, 2015
Last verified: February 2015
The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)

Condition Intervention Phase
Deep Vein Thrombosis
Pulmonary Embolism
Drug: Apixaban
Drug: Unfractionated Heparin (UFH)
Drug: Warfarin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Active-control, Multicenter, Randomized, Open-label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Major bleeding and Clinically Relevant Non-major bleeding [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • symptomatic VTE or VTE-related death [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • thrombtic burden deterioration [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Major bleeeding [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • All bleeding [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: January 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apixaban Drug: Apixaban
10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
Active Comparator: UFH/Warfarin Drug: Unfractionated Heparin (UFH)
Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more
Drug: Warfarin
Dosing for 24 weeks to target INR range between 1.5-2.5


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute symptomatic proximal DVT with evidence of proximal thrombosis
  • Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches

Exclusion Criteria:

  • Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.
  • Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
  • Subjects requiring dual anti-platelet therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01780987

Aichi Medical University Hospital
Nagakute, Aichi, Japan, 480-1195
Toho University Sakura Medical Center
Sakura, Chiba, Japan, 285-8741
Kokura Memorial Hospital
Kitakyusyu, Fukuoka, Japan, 802-8555
Hiroshima General Hospital
Hatsukaichi, Hiroshima, Japan, 738-8503
Teine Keijinkai Hospital
Sapporo, Hokkaido, Japan, 006-8555
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa, Japan, 920-0293
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, Japan, 245-8575
Yokohama Minami Kyousai Hospital
Yokohama, Kanagawa, Japan, 236-0037
Mie University Hospital
Tsu, Mie, Japan, 514-8507
National Hospital Organization Okayama Medical Center
Okayama City, Okayama, Japan, 701-1192
Kinki University Hospital
Osakasayama, Osaka, Japan, 589-8511
National Cerebral and Cardiovascular Center Hospital
Suita-shi, Osaka, Japan, 565-8565
St. Luke's International Hospital
Chuo-ku, Tokyo, Japan, 104-8560
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, Japan, 152-8902
Japanese Red Cross Musashino Hospital
Musashino, Tokyo, Japan, 180-8610
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Saiseikai Kumamoto Hospital
Kumamoto, Japan, 861-4193
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01780987     History of Changes
Other Study ID Numbers: B0661024  CV185160  BMS 
Study First Received: January 29, 2013
Last Updated: February 9, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Pulmonary Embolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Calcium heparin
Enzyme Inhibitors
Factor Xa Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Serine Proteinase Inhibitors processed this record on May 25, 2016